FeverNCT01812785
Study to Investigate the Causes of Fever in Children Living in Urban Dar es Salaam and Rural Ifakara
An observational study of Fever and Children, run by Swiss Tropical & Public Health Institute at 2 sites in Tanzania.
Trial summary
The goal is to improve the evidence-based management of fever cases seen in outpatient clinics in malaria endemic countries, through a better understanding of the value of accurate malaria diagnosis, and through an improved understanding of the other causes of fever in children. Read more about this study
- Who is it for?
- Ages 2 months to 10 years
- Conditions the study is for
- Fever, Children, Infectious Diseases
- How many people
- 1,010 participants
- Where
- 2 sitesTanzania
- Study dates
- Jan 2008to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Consecutive patients aged 2 months to 10 years presenting at the outpatient clinic of Amana district hospital in Dar es Salaam, and at the outpatient clinic of St-Francis designated-district hospital in Ifakara, Kilombero District.
Who may be able to join
- axillary temperature of 38°C or more
- first consultation for the present problem
- history of fever lasting for one week or less
- main complaint was not an injury or trauma
- no report of an antimalarial or antibiotic medicine taken during the previous week
Who cannot join
- severe malnutrition
- categorized as P1 (requiring immediate live saving procedures)
Trial locations and contacts
2 sites in 1 country.
Tanzania2 sites
Amana district hospital
Dar es Salaam, Dar es Salaam Region
St Francis hospital
Ifakara, Morogoro
About this study
The goal is to improve the evidence-based management of fever cases seen in outpatient clinics in malaria endemic countries, through a better understanding of the value of accurate malaria diagnosis, and through an improved understanding of the other causes of fever in children. The objective is to describe systematically (as much as possible) the etiologies of fever in children in an urban and in a rural environment of sub-Saharan Africa.
- Conditions
- Fever, Children, Infectious Diseases
- Keywords
- Fever, Children, Non-malaria fevers, Diagnosis
- Medical subject headings
- Fever, Communicable Diseases, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of each disease and proportion of fevers of unknown origin in febrile children aged 2 months to 10 years attending an Outpatient Department of a district hospital in Dar es Salaam and in Ifakara
Measured: December 2011
Secondary outcomes (1)
Clinical and laboratory predictors of each disease
Measured: December 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,010 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Blaise Genton, prof, Principal investigator, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812785
- Sponsor's protocol ID
- Feverstudy
- Other IDs
- SNSF
- Status last verified
- Mar 2013
- First submitted
- 14 Mar 2013
- Last updated
- 18 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Investigate the Causes of Fever in Children Living in Urban Dar es Salaam and Rural Ifakara
- ClinicalTrials.gov ID
- NCT01812785
- Acronym / sponsor ID
- Feverstudy
- Conditions
- Fever, Children, Infectious Diseases
- Keywords
- Fever, Children, Non-malaria fevers, Diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,010 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- University Hospital, Geneva
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to improve the evidence-based management of fever cases seen in outpatient clinics in malaria endemic countries, through a better understanding of the value of accurate malaria diagnosis, and through an improved understanding of the other causes of fever in children. The objective is to describe systematically (as much as possible) the etiologies of fever in children in an urban and in a rural environment of sub-Saharan Africa.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Consecutive patients aged 2 months to 10 years presenting at the outpatient clinic of Amana district hospital in Dar es Salaam, and at the outpatient clinic of St-Francis designated-district hospital in Ifakara, Kilombero District.
Key inclusion criteria (5 listed)
- axillary temperature of 38°C or more
- first consultation for the present problem
- history of fever lasting for one week or less
- main complaint was not an injury or trauma
- no report of an antimalarial or antibiotic medicine taken during the previous week
Key exclusion criteria (2 listed)
- severe malnutrition
- categorized as P1 (requiring immediate live saving procedures)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of each disease and proportion of fevers of unknown origin in febrile children aged 2 months to 10 years attending an Outpatient Department of a district hospital in Dar es Salaam and in Ifakara
Time frame: December 2011
1 secondary outcome
Clinical and laboratory predictors of each disease
Time frame: December 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blaise Genton, prof principal investigator
Swiss Tropical & Public Health Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever and Children, run by Swiss Tropical & Public Health Institute at 2 sites in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of each disease and proportion of fevers of unknown origin in febrile children aged 2 months to 10 years attending an Outpatient Department of a district hospital in Dar es Salaam and in Ifakara (time frame: December 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2013.